On April 4th, 2017, EG Life Sciences will host a breakfast event at MassBio that will feature Gary C. du Moulin, Ph.D., M.P.H., RAC who will present "Core Components for Contamination Prevention and Control in Biopharmaceutical Manufacturing Operations." Gary recently retired as Senior Director of Quality Aseptic Control for Genzyme (a Sanofi company) where he participated in the development and execution of robust quality systems for Genzyme's products including biologics and cell based therapies.
Below is an abstract of the presentation:
A 2016 review of FDA’s MedWatch Safety Alert Archive for Drugs and Therapeutic Biological Products revealed that 25% (15 of 60) of safety alerts involved microbial contamination or lack of sterility assurance. Moreover, according to a survey conducted by BioPlan, 2016 between 2 and 2 1/2% of biopharmaceutical production in process batches are lost to contamination. Contamination control constitutes a never ending concern for biopharmaceutical manufacturing operations requiring extraordinary attention to detail by a multidisciplinary group of dedicated individuals. Drawing upon 26 years’ experience in cell therapy and biological product manufacturing the core components for contamination prevention and control are the focus of this presentation.
Through an understanding of the multifactorial origins, dynamics of microbial contamination within the manufacturing environment, mode of transfer and mechanisms of amplification application of robust countermeasures directed at protecting the batch can be deployed. Creation of a proactive environmental action committee drawn from a number of manufacturing site based operations disciplines can be an essential element of control to facilitate, investigate, interdict and prevent contamination events. Contamination control must be an inclusive and highly visible activity supported by senior management with an ability to promptly deploy countermeasures when adverse trends warrant such action.